Method of growing a graft member in a living body

ABSTRACT

A cluster of tubular tissue dies in a die holder is inserted lengthwise in a stab wound. Each die tube is perforated and contains a cloth tube spaced outward from a central mandrel in the tube. Ingrowth of tissue encapsulates the cloth tube and fills the space between the cloth tube and mandrel forming a graft tube containing the cloth tube as a reinforcing member adjacent its outer surface and remote from the lumen formed by the mandrel. The die cluster containing the graft tubes is removed lengthwise from a second stab wound adjacent one end of the cluster.

United States Patent 1 Sparks 1 Jan.2,1973

[54] METHOD OF GROWING A CRAFT MEMBER IN A LIVING BODY [76] Inventor:Charles II. Sparks, 3725 S. E. Martins St., Portland, Oreg. 97202 [22]Filed: Aug. 30, 1971 [21] Appl. No.: 175,915

Related US. Application Data [60] Division of Ser. No. 823,287, May 9,1969, Pat. No. 3,625,198, which is a continuation-in-part of Ser. No.655,838, July 25,1967, Pat. No. 3,514,791.

[52] US. Cl. ..l28/l R, 128/334 R [51] Int. Cl. ..A6lb 19/00, A61f 1/24[58] Field of Search ..3/l, DIG. 1; 128/334 R, 1 R,

128/92 R, 92 C, 92 G [56] References Cited OTHER PUBLICATIONS Ear Molds,Peer Type, Catalog No. 6452, Vitallium Surgical Appliances Catalog,Austenal Laboratories, Inc. Surgical Div., 224 E. 39th St., N.Y., N.Y.,page 20, March 1948.

Primary Examiner-Richard A. Gaudet Assistant Examiner-Ronald L. FrinksAttorney-Lee R. Schermerhorn [57] ABSTRACT A cluster of tubular tissuedies in a die holder is inserted lengthwise in a stab wound. Each dietube is perforated and contains a cloth tube spaced outward from acentral mandrel in the tube. Ingrowth of tissue encapsulates the clothtube and fills the space between the cloth tube and mandrel forming agraft tube containing the cloth tube as a reinforcing member adjacentits outer surface and remote from the lumen formed by the mandrel. Thedie cluster containing the graft tubes is removed lengthwise from asecond stab wound adjacent one end of the cluster.

6 Claims, 13 Drawing Figures PEGTORALI S MAJOR MUSCLE SERRATUS ANTERIORMUSCLE PATENTEDJAH 2 1975 saw 1 or 3 YINVENTOR CHARLES H. SPARKSPATENTEDM 2 I975 SHEET 2 OF 3 RAM 8 AJOR PEG SERRATUS ANTERIOR MUSCLEPATENTEDJAN 2191s 3.707.958

snm a or 3 INVENTOR CHARLES H. SPARKS 14' orne METHOD OF GROWING A GRAFTMEMBER IN A LIVING BODY CROSS REFERENCES TO RELATED APPLICATIONS Thisapplication is a division of Ser. No. 823,287 filed May 9, 1969, now US.Pat. No. 3,625,198, which is a continuation-in-part of Ser. No. 655,838filed July 25, 1967, now US. Pat. No. 3,514,791.

BACKGROUND OF THE INVENTION This invention relates to a novel method ofgrowing a graft member in a living body and has particular reference toan improved method of implanting dies in the body for growing the graftmembers.

My prior application, Ser. No. 655,838, discloses a number of individualdies for growing grafts for different purposes. It is often desired togrow a plurality of grafts at the same time, as for example, when agraft tube is needed of greater length than can be provided in a singleimplantable die. Also, the need may arise to grow different sizes ortypes of grafts simultaneously.

Further, an improved technique for implantation is desired. It would beadvantageous to obviate the necessity for tying the die or dies to thebone structure of the body and to provide a method of implantation whichwould not require a large incision.

Objects of the invention are, therefore, to provide an improved tissuegraft, to provide an improved cloth reinforcement for a tissue graft, toprovide an improved arrangement of a cloth reinforcement within a diecavity, to provide an improved die for forming a tissue graft, toprovide a novel die cluster for growing a plurality of tissue graftssimultaneously, and to provide an improved method for implanting a dieor die cluster for growing grafts.

SUMMARY OF THE INVENTION According to the present invention a clothreinforcing member is impregnated with a stiffening agent so that thecloth may be pre-shaped and will maintain itself in a position in a diecavity where it will be located adjacent the outer surface of the grafttissue. When a plurality of grafts are needed, a number of dies areassembled in a die cluster for implantation as a unit.

Instead of tying the die or die cluster to the rib cage to avoidmovement in the body, it is inserted under a layer of muscles overlyingthe rib cage. The muscles themselves hold the die or die cluster infixed position against the ribs whereby the dies are easily insertableand removable through a relatively small incision.

Other objects and advantages will become apparent and the invention willbe better understood with reference to the following description of thepreferred embodiment illustrated in the accompanying drawings. Variouschanges may be made, however, in the details of the method and in theform of construction of the dies and certain features may be usedwithout others. The invention is of particular advantage in growingantogenous grafts within the body of the same patient who is to receivethe grafts but the invention may also be used in growing homografts andheterografts if desired.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a diecluster embodying the principles of the invention; I

FIG. 2 is an exploded view of the die cluster in FIG. 1 with partsremoved and parts broken away;

FIG. 3 is a sectional view on the line 3-3 in FIG. 1;

FIG. 4 is a sectional view on the line 4-4 in FIG. 1;

FIG. 5 is a fragmentary front elevation view of a patient, showing thedie cluster of FIG. 1 implanted;

FIG. 6 is an enlarged view of a portion of FIG. 5 showing the use of apathfinder for preparing an opening to receive the die cluster;

FIG. 7 is a view similar to FIG. 6 showing a first step in the removalof the dies;

FIG. 8 is a view similar to FIG. 7 showing a subsequent step in removalof the dies;

FIG. 9 is an enlarged view of a portion of FIG. 8 with parts in section;

FIGS. 10 and 11 are views similar to FIGS. 7 and 8 showing subsequentsteps in removal of the die cluster;

FIG. 12 is a fragmentary perspective view showing a preliminary step inremoval of a graft from a die; and

FIG. 13 is a similar view showing the final step in removal of a graftfrom a die.

DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 shows a die cluster 10containing a plurality of dies 11 for implantation as a unit. By way ofexample, tubular dies are illustrated for growing artery grafts and thelike. Each die comprises essentially an outer cylindrical metal tube 12containing perforations 13 and an inner cylindrical metal mandrel 14 ofsmaller diameter. The annular space between the outer surface of themandrel and the inner surface of tube 12 forms a die cavity- 15 forgrowing a tube graft. Tube 12 and mandrel 14 may be made of a suitableplastic if desired.

Each tube 12 and mandrel 14 is supported at its front end on a plasticferrule 20 and at its rear end on a plastic ferrule 21. In the middledie of the cluster these ferrules are mounted on an anchor rod 22 whilein the two outside dies the ferrules are mounted on removable rods 23.The two ferrules 21 on rods 23 are secured thereto by pins 24 while theother ferrules are not attached to their supporting rods. Each ferrulehas a stepped end flange portion 25 to support tube 12 and an interiorshoulder portion 26 supporting mandrel 14 in concentric position withintube [2. Flange 25 on each ferrule 20 has the same diameter as the.outside diameter of tube 12 while flange 25 on each ferrule 21 is oflarger diameter for a purpose which will presently appear.

Mounted on the rear end of anchor rod 22 is a head 30 having'hinge pins31 for pivotal connection with cross bars 32. The outer end of eachcross bar32 is provided with a threaded hole 33 and its intermediateportion is provided with a smooth hole 34. The rear ends of rods 23 arereceived in the holes 34 and a pair of tie rods 35 have threadedengagement with the end holes 33.

The assemblage thus far described is retained in the cluster by a frontcross bar 40. Cross bar 40 has a central hole 41 to receive anchor rod22, end holes 42 to receive tie rods 35, and intermediate holes 43 toreceive the removable rods 23, all of these holes being smooth bore. Thefront ends of rods 22 and 35 are threaded at 44 to receive nuts 45. Nuts45 hold all the parts in place and immobilize the hinged joints at 31 toform a rigid relatively flat unit for implantation. Cross bars 32 and 40and rods 22 and 35 form a frame or die holder which contains the dies 11in side by side relation.

In order to prevent adherence of the graft to the mandrel 14 the outersurface of the mandrel is preferably coated with a suitable releaseagent such as Dow Corning resin R-67l or Teflon. To strengthen the grafta cloth reinforcing member 50 is inserted in die cavity 15. Member 50 ispreferably made of woven or knitted seamless tubular construction havingsuch diameter that it will lie against or substantially adjacent outertube 12 in spaced relation to mandrel 14. The structural advantages anddisadvantages of both woven and knitted materials are well understood bypersons skilled in the art. Tube 50 is preferably made of a suitablesynthetic fiber such as Dacron. This reinforcement is most effective toprevent leakage or rupture of the graft under arterial blood pressure ifthe reinforcement is located adjacent the outer surface of the grafttube and relatively remote from the inner surface or lumen.

In order to make the cloth tube 50 support itself and lie substantiallysmoothly against the inside of tube 12, the cloth is preferablyimpregnated with a suitable stiffening agent such as silicone rubber. Apreferred procedure is to dip the tube several times in a 1:5 suspensionof crude (unvulcanized) silicone rubber in xylene. The tube is hung todry between dips. It is then stretched on a glass rod having a diameterequal to the inside diameter of tube 12 and vulcanized in stretchedcondition. This accomplishes a desirable sizing operation. When thecloth tube is removed from the glass rod it holds its diameter, and wheninstalled in the die it automatically positions itself snugly againstthe inner surface of tube 12. Impregnation and vulcanization in themanner described also causes the cloth tube to hold its length andcauses the junctures of the threads to become locked together, both ofwhich stabilizing factors are especially advantageous with a knittedtype of ple are not intended to limit the invention but will serve todefine the preferred proportions of the ingredients used. First, 50 cc.of the patients blood is drawn from a vena-puncture into a syringecontaining 2 cc. of a solution of 1 million units of penicillin and 1gram of streptomycin dissolved in 20 cc. of normal saline solution. Thenan assembled and sterile die cluster as shown in FIG. 1 is placed in ametal laboratory boat and covered with the blood solution justdescribed. The die cluster is allowed to remain in the blood solutionfor about 25 minutes so that a strong, firm clot forms, filling the diecavities 15.

FIGS. 5 and 6 illustrate the method of implantation of the prepared diecluster. A transverse incision A is made in the skin immediately abovethe costal margin across the mid-clavicular line as shown in FIG. 5.This incision is carried down to the serratus anterior muscle.

If the patient is right-handed this incision is made on the left side,as shown; if the patient is left-handed the incision would be made onthe right side. In instances where two long graft tubes are needed, adie cluster is implanted on each antr0-lateral chest wall.

After incision A has been made in the skin, the serratus anterior muscleis incised in the direction of its fibers astindicated at B in FIG. 5. Aflat spatula-shaped pathfinder 60 is inserted and passed on the rib cagesupero-medially, aiming at the junction of the middle and medial thirdsof the clavicle as shown in FIG. 6. In the proximal one-half of thepassage considerable resistance is met as a result of the origins of theserratus anterior muscle. These must be pushed forcefully off the ribs.Essentially no resistance is met as the instrument passes beneath thepectoralis major muscle in the upper half of the passage. Thus, thepathfinder forms a pocket to receive the die cluster. Then thepathfinder 60 is withdrawn.

The die cluster 10 prepared as above described is lifted from the boatand the back end having the jointed cross bar 32 is inserted in the samemanner as pathfinder 60 in FIG. 6. The die cluster is pushed up alongthe path made by pathfinder 60 until the lower end of the die clusterlies above incision A as shown in FIG. 5. Finally, the incision isclosed in layers using interrupted sutures and a light sterile dressingis applied. The patient is maintained on penicillin and streptomycinuntil hospital discharge. The patient is normally discharged from thehospital 1 or 2 days after in plantation of the dies and resumes normalactivity. The die cluster may be made to contain fewer or more thanthree dies if desired.

The serratus anterior muscle and the pectoralis major muscle clamp thedie cluster firmly and rigidly against the ribs and prevent any movementof the die cluster, making it unnecessary to provide any mechanicalattachment to the ribs. This makes it possible to insert and remove thedie cluster endwise through a relatively small incision which healsquickly. While the die cluster is implanted, body tissue from thepatient grows through holes 13 into the die cavity replacing the bloodnutrient and encapsulating the reinforcing cloth tube 50. This ingrowthof tissue completely fills the die cavity and forms the ultimate graft.Mandrel l4 casts a smooth surface on the lumen of the graft tube.

Two or three months later the patient is readmitted to the hospital forthe grafting procedure. The grafts are usually complete in two monthsand are consistently complete at three months. The procedure forremoving the dies is 'shown in FIGS. 7 to 11. A 3 inch incision C ismade over the lower end of the die cluster and perpendicular to its longaxis. This incision is carried down through the muscle to the dies.Lower cross bar 40 and the lower 1 cm. of the dies are exposed by sharpdissection-Nuts 45 are removed and cross bar 40 is removed as shown inFIG. 7, and tie rods 35 are unscrewed from threaded holes 33 in hingedcross bar 32.

Then a cylindrical cutter 65 is passed onto the exposed end of a dieand, using a rotary oscillating motion, is passed up over the entirelength of the die as shown in FIGS. 8 and 9. The larger diameter flanges25 on plastic ferrules 21 provide stops for the cutter. This operationsevers the necks of tissue 66 which have ingrown through the holes 13 intube 12. The cutter and die are then removed and the die containing thegraft is removed from the cutter. The remaining two dies are removed inthe same manner. In removing the dies, rods 23 come outwith the dieswhile anchor rod 22 remains in the patient.

At this stage only the center anchor rod 22 and the upper jointed crossbar 32 remain in the patient as shown in FIG. 10. These parts areremoved by firm traction on the anchor rod as shown in FIG. 11, causingthe ends of cross bar 32 to pivot back to trailing position, as shown.Incision C is closed in layers using interrupted silk sutures.

Using a surgical knife, the outer surface of each tube 12 is completelycleansed of all fragments of tissue and the mandrel 14 is extracted fromeach die. This is done by pushing the mandrel from one end to expose itsother end which is then grasped with a small hemostat and extracted.

A gall bladder probe 70 is then passed between the graft G and the innersurface of tube 12 at several points around the circumference as shownin FIG. 12. With each pass, it is passed throughout the length of thedie, releasing the graft from the outer tube by withdrawing the necks oftissue 66 inwardly through the holes 13. After the graft is completelyfreed from tube 12 in this manner, it may be grasped at one end with ahemostat and extracted as shown in FIG. 13.

When a long graft tube is needed, the individual grafts from the threedies may be sutured together end to end over a glass rod, the ends ofthe grafts preferably being cut on a 45 degree angle for eachanastomosis. In this manner a graft tube approximately 19 inches longmay be made.

When only a short graft is needed, a single die similar to the centraldie is used with a modified form of die holder. In such case, cross bar40 and hinged cross bars 32 are made shorter and holes 34 and 43 areomitted. This makes a narrower and more compact unit placing the tierods 35 adjacent opposite sides of the single die on anchor rod 22. Whenthe die is round, the die holder prevents rotation in the body. When thedie and die holder are of small size, the unit may simply be inserted ina stab wound directed as explained in connection with FIGS. 5 and 6.

The invention is not limited to tube grafts. Dies for other graftmembers may also be implanted essentially as described in connectionwith FIGS. 5 and 6. When the die is not round, the die holder may beeliminated if desired but a die holder may still be desirable forconvenience in handling a single die or cluster of dies.

Having now described my invention and in what manner the same may beused, what I claim as new and desire to protect by Letters Patent is:

l. The method of forming a graft member comprising providing aperforated die having a die cavity; cutting an incision in the skintransversely immediately above the costal margin across themid-clavicular line carrying the incision down to the serratus anteriormuscle, incising said muscle in the direction of its fibers; inserting aflat, elongated pathfinder into said opening in an upward direction,passing said pathfinder on the rib cage supero-medially aiming at thejunction of the middle and medial thirds of the clavicle and pushing theserratus anterior muscle forcefully off the ribs; and i i i ihllle dsfifii iiliikdli flfi s2336i; all terior muscle clamping the die firmlyagainst the ribs; closing said incision and leaving said die in saidpocket for a time sufficient for connective tissue to grow into the dieand form said graft member within the die cavity; making an incision forremoval of said die; cutting said connective tissue on the outsidesurface of the die; removing the die containing said graft member; andthen removing the graft member from the die.

2. The method of claim 1 wherein a cluster of dies in a die holder isimplanted as a unit in said pocket.

3. The method of implanting a die in a living body for forming a graftmember comprising cutting a transverse incision in the skin immediatelyabove the costal margin across the mid-clavicular line carrying theincision down to the serratus anterior muscle, incising said muscle inthe direction of its fibers; inserting a flat, elongated pathfinder intosaid incision in an upward direction, passing said pathfinder on the ribcage supero-medially aiming at the junction of the middle and medialthirds of the clavicle and pushing the serratus anterior muscleforcefully off the ribs; withdrawing said pathfinder and inserting saiddie in the position prepared by the pathfinder, said serratus anteriormuscle clamping the die firmly against the ribs without mechanicalanchoring means.

4. The method of implanting a die in a living body for forming a graftmember in the die comprising cutting an incision in the skin, insertinga flat, elongated pathfinder into said incision separating the bodytissues and forming a pocket to receive said die, withdrawing saidpathfinder, inserting said die in said pocket, and closing saidincision.

5. The method of claim 4 wherein said pathfinder is inserted under alayer of muscle so that the muscle will clamp said die in said pocket.

6. The method of claim 5 wherein said pathfinder is inserted betweensaid layer of muscle and an underlying bony structure so that the musclewill clamp the die against said bony structure.

1. The method of forming a graft member comprising providing aperforated die having a die cavity; cutting an incision in the skintransversely immediately above the costal margin across themid-clavicular line carrying the incision down to the serratus anteriormuscle, incising said muscle in the direction of its fibers; inserting aflat, elongated pathfinder into said opening in an upward direction,passing said pathfinder on the rib cage supero-medially aiming at thejunction of the middle and medial thirds of the clavicle and pushing theserratus anterior muscle forcefully off the ribs; and then withdrawingsaid pathfinder; inserting said die in the pocket formed by saidpathfinder; said serratus anterior muscle clamping the die firmlyagainst the ribs; closing said incision and leaving said die in saidpocket for a time sufficient for connective tissue to grow into the dieand form said graft member within the die cavity; making an incision forremoval of said die; cutting said connective tissue on the outsidesurface of the die; removing the die containing said graft member; andthen removing the graft member from the die.
 2. The method of claim 1wherein a cluster of dies in a die holder is implanted as a unit in saidpocket.
 3. The method of implanting a die in a living body for forming agraft member comprising cutting a transverse incision in the skinimmediately above the costal margin across the mid-clavicular linecarrying the incision down to the serratus anterior muscle, incisingsaid muscle in the direction of its fibers; inserting a flat, elongatedpathfinder into said incision in an upward direction, passing saidpathfinder on the rib cage supero-medially aiming at the junction of themiddle and medial thirds of the clavicle and pushing the serratusanterior muscle forcefully off the ribs; withdrawing said pathfinder andinserting said die in the position prepared by the pathfinder, saidserratus anterior muscle clamping the die firmly against the ribswithout mechanical anchoring means.
 4. The method of implanting a die ina living body for forming a graft member in the die comprising cuttingan incision in the skin, inserting a flat, elongated pathfinder intosaid incision separating the body tissues and forming a pocket toreceive said die, withdrawing said pathfinder, inserting said die insaid pocket, and closing said incision.
 5. The method of claim 4 whereinsaid pathfinder is inserted under a layer of muscle so that the musclewill clamp said die in said pocket.
 6. The method of claim 5 whereinsaid pathfinder is inserted between said layer of muscle and anunderlying bony structure so that the muscle will clamp the die againstsaid bony structure.